CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 82 enrolled
Drug / intervention
Furosemide Cohort 1 +3 moredrug
Likely dose
Furosemide Cohort 1 1 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02527798
NCT02527798Phase 2Completed

Safety of Furosemide in Premature Infants at Risk of Bronchopulmonary Dysplasia

University of North Carolina, Chapel Hill·interventional·Posted Aug 19, 2015·Updated Dec 28, 2021

In Brief

A Phase 2 clinical trial evaluating Furosemide Cohort 1, Furosemide Cohort 2, and 2 other interventions for Bronchopulmonary Dysplasia. Completed, enrolled 82 participants across 21 sites.

Detailed Summary

This study will describe the safety of furosemide in premature infants at risk of bronchopulmonary dysplasia and determine the preliminary effectiveness and pharmacokinetics (PK) of furosemide. Funding Source - FDA OOPD

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 19, 2015
Enrollment StartNov 27, 2015
Primary CompletionOct 15, 2019
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 10.9 years ago

Interventions

Furosemide Cohort 1drug

furosemide 1 mg/kg q 24 hours IV or 2 mg/kg q 24 hours enterally Cohorts will be enrolled sequentially after a safety review.

Furosemide Cohort 2drug

furosemide 1 mg/kg q 6 hours IV or 2 mg/kg q 6 hours enterally Cohorts will be enrolled sequentially after a safety review.

Furosemide Cohort 3drug

furosemide 2 mg/kg q 6 hours IV or 4 mg/kg q 6 hours enterally Cohorts will be enrolled sequentially after a safety review.

Placeboother

Sugar water will be administered in a equivalent volume as drug intervention.